Drug Safety Information for PIROXICAM (Piroxicam)

Safety-related Labeling Changes for FELDENE (PIROXICAM) Rx Drug: FDA Link

Adverse Drug Reactions for PIROXICAM* (Piroxicam)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with PIROXICAM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain185
2Headache162
3Nausea158
4Drug ineffective*145
5Drug hypersensitivity136
6Dyspnoea133
7Arthralgia129
8Depression123
9Vomiting123
10Dizziness113
11Fatigue112
12Anxiety109
13Drug interaction106
14Pruritus*106
15Diarrhoea102
16Pain in extremity100
17Asthenia99
18Hypertension99
19Rash*96
20Pyrexia95

* This side effect also appears in "Top 10 Side Effects of PIROXICAM " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking PIROXICAM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication1021
2Pain807
3Arthritis681
4Arthralgia*548
5Rheumatoid arthritis514
6Osteoarthritis*399
7Back pain*362
8Ill-defined disorder256
9Inflammation170
10Ankylosing spondylitis168

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for PIROXICAM

Total Reports Filed with FDA: 17443


Number of FDA Adverse Event Reports by Patient Age for PIROXICAM

Total Reports Filed with FDA: 17443*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Piroxicam (Brexidol, Feldene melt, Larapam, Feldene, Piroxicam)

Charts are based on 17443 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and PIROXICAM Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.